Cerebral StrokeAbotMotNCT01072032
Cortical and Biomechanical Dynamics of Ankle Robotics Training in Stroke
A study testing Anklebot (Ankle Robot) in people with Cerebral Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Reduced mobility is often a long-term problem facing those who have chronic leg weakness resulting from stroke. Recent innovations in stroke therapy have applied motor learning principles to improve motor skills through regular practice of activities using the weaker limb. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Cerebral Stroke
- What is being tested?
- Anklebot (Ankle Robot)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke greater than 3 months prior
- Residual hemiparetic gait with observable asymmetry in the gait pattern.
- Women or men aged 21 to 85 years
- Completed all conventional physical therapy.
- Adequate language and neurocognitive function to participate in training, testing, and to give informed consent.
- Minimal ankle flexion in either direction (dorsi- or plantar-)
Who cannot join
- MMSE score < 23 (9th grade education or more) or MMSE score < 17 (8th grade education or less)
- CES-D score > 16
- Clinical history of orthopedic, chronic pain or severe neuromuscular disorders restricting participation in a short term ankle movement training paradigm.
- Severe or global receptive aphasia which confounds reliable testing and training.
- Women of child-bearing potential, if there is any self-reported chance that they may be pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Reduced mobility is often a long-term problem facing those who have chronic leg weakness resulting from stroke. Recent innovations in stroke therapy have applied motor learning principles to improve motor skills through regular practice of activities using the weaker limb. Because the ankle provides critical torques for normal walking and mobility function, impairments at the affected ankle pose a major limitation to achieving optimal mobility recovery. To address this we have developed a novel ankle robot (Anklebot) to enhance physical therapy for improving walking and mobility after stroke. This computer controlled device provides assistance when users cannot complete a movement, but will not assist if the user is active.
Motor learning requires active involvement in task-related practice to mediate brain plasticity. While voluntary movement is important to remodel motor control circuits, the brain mechanisms of reward and motivation also can play an important role. Core brain networks involved in reward and motivation increase a person's involvement with their surroundings, to focus attention and to prompt one to approach reward and avoid punishment. This increased involvement and the elevated emotions associated with it have been shown to enhance performance, memory and learning.
The purpose of this study is to investigate responses of brain and motor behavior of stroke patients who use the Anklebot during a 3-week / 3-session/week motor learning based training. These responses are compared to a 3-week delayed entry period in which the participants will perform an at-home walking program of equal time. After the 3-week delayed entry walking program, subjects are divided into low and high reward-feedback groups. The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the researchers. The high-reward group receives cumulative scores and ongoing social support, are eligible for prizes during each session and at the study's completion. All subjects play the games as noninvasive electroencephalography and electromyography record brain and muscle activity. In addition to analyzing brain information before and after the Anklebot training, ankle motor control and walking functions are also assessed immediately before and after the first and last robotic training sessions.
Read the detailed description
After informed consent is obtained, this pilot study will require at least eleven visits for all subjects. The first visit will entail screening and eligibility tests that last about 3 hours and will occur at the VAMC (Veteran's Administration Medical Center) in the Geriatric Assessment Clinic (GAC). The second and third visits will last approximately 3 hours at the VAMC Human Motor Performance Laboratory and will involve collection of noninvasive EEG, surface EMG and ECG, and practice of ankle movements by using the ankle robot to play video games. In addition measures of gait and balance function will be assessed pre- and post- the Anklebot training. For the next 3-weeks the subjects will take part in an at-home, monitored (log) walking program. The next seven visits (the training program) entail further practice of ankle movements by using the ankle robot to play video games, collection of motor control data but not the collection of any electrophysiological data.. Visit eleven (final) is the same as visits 2 \& 3.
Visit 1: Screening evaluations include review of medical records, medical and neurologic examinations to determine eligibility. Clinical evaluations will also include the Mini Mental State Exam (MMSE) and the Center for Epidemiologic Study (CES-D). Clinical suspicion or evidence on these screening instruments of dementia, depression, or other cognitive deficits that could interfere with the study will preclude further study evaluation and prompt referral to psychiatry or other appropriate health professional for further evaluation. The Automated Neuropsychological Assessment Metrics (ANAM) is also administered as a comprehensive neuropsychological tool for measuring multiple facets of neuropsychological processes that pertain to cognitive function and motor learning. In addition participants will be asked to walk 10 meters 3 times across a gait measuring mat at their preferred speed while in a safety harness and accompanied (not assisted) by an experienced research assistant. This will help determine their deficit severity for grouping during data analysis. Finally, a standard neurological examination is conducted by medically credentialed staff.
Visit 2 \& 3 \& 11: After study enrollment and medical screening, subjects will be tested with the Anklebot while EEG, EMG, and heart rate (ECG) are recorded.
First, subjects will be fitted with a stretch-lycra cap that houses 64 recessed EEG sensors formed from tin. The participant's skin will be lightly abraded or rubbed with the end of a Q-tip at each sensor site to remove oil and dead epidermal tissue to establish good conductance of the EEG signal. The skin will not be broken. Using a blunt applicator attached to a syringe, an FDA-approved non-toxic conducting gel will then be applied through an opening in each of the 64 recording sensors to establish continuous contact of the gel between the skin at the recording sites and the corresponding sensors. Recording sensors will also be positioned on the skin above and below the left eye to monitor eye movements as well as on both ear lobes to serve as "non-brain" reference sites. A ground electrode site will be applied in the frontal region. The eye-channel and reference sites will be lightly abraded with a pad, rubbed with alcohol, and prepared with the conducting gel to enable continuous connection between the scalp and the sensor surface. Also, surface EMG electrodes will be applied to tibialis anterior, gastrocnemius, and, if needed, the peroneal muscles of the paretic leg. Leads for ECG recording will be applied bilaterally to locations immediately inferior to the clavicles.
Once the set-up is complete, subjects will be asked to walk 10 m over an instrumented gait mat to record gait parameters during 3 preferred and 3 fastest walking trials. Subjects will be asked to repeat these walking tasks while performing a concurrent cognitive task consisting of solving and verbally reporting answers to simple arithmetic problems. They will wear a gait belt and be attended closely by research staff as they walk and receive seated rests as required to prevent fatigue. A second test will measure balance control by recording 30 second trials of postural sway during quiet standing on a force plate. Three balance conditions include eyes open, eyes closed, and eyes open while performing a concurrent cognitive task consisting of solving and verbally reporting answers to simple arithmetic problems. Seated rests will be provided as needed.
After baseline functional testing participants will be seated in a chair and the ankle robot will be attached to their paretic leg by means of an orthopedic knee brace and an orthopedic shoe. Pads and cushioning will be applied as needed for proper fitting, and the knee brace will be mounted to the chair for stability. The leg will rest on a cushioned support with the knee at 45 degrees and the foot free to move.
Once the set-up is completed, subjects will be asked to "play" a series of videogames by plantar- or dorsi-flexing the paretic ankle to move a corresponding cursor on a computer screen in order to hit slowly moving targets. The first game is about two-minutes duration and is played without robotic assistance to assess subjects' baseline motor control and ability. Subsequently, 6 games of about 4-minutes duration will provide differing levels of robotic support to guide or encourage the subjects to complete the prescribed ankle movements. The nature and amount of robotic support will be varied across the session to promote short-term motor learning and control of the paretic ankle. Upon completion of the performance-based training series, a repeat of the two-minute unassisted game completes the session.' Finally, subjects will be asked to repeat the postural sway and walking tests as before.
Visits 4-10: participants will be seated in a chair and the ankle robot will be attached to their paretic leg by means of an orthopedic knee brace and an orthopedic shoe. Pads and cushioning will be applied as needed for proper fitting, and the knee brace will be mounted to the chair for stability. The leg will rest on a cushioned support with the knee at 45 degrees and the foot free to move.
Once the set-up is completed, subjects will be asked to "play" a series of videogames by plantar- or dorsi-flexing the paretic ankle to move a corresponding cursor on a computer screen in order to hit slowly moving targets. The first game is about two-minutes duration and is played without robotic assistance to assess subjects' baseline motor control and ability. Subsequently, 6 games of about 4-minutes duration will provide differing levels of robotic support to guide or encourage the subjects to complete the prescribed ankle movements. The nature and amount of robotic support will be varied across the session to promote short-term motor learning and control of the paretic ankle. Upon completion of the performance-based training series, a repeat of the two-minute unassisted game completes the session. During these training sessions no electrophysiological data will be acquired, only motor control data acquired by the Anklebot itself.
- Conditions
- Cerebral Stroke
- Being tested
- Anklebot (Ankle Robot)
- Keywords
- EEG, Robotics (ankle), Motor-learning, Brain Plasticity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anklebot (Ankle Robot)Device
Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery
| Study group | Role | What they receive |
|---|---|---|
| Low-Reward | Experimental | Low-Reward Anklebot training Group: The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team. Receives: Device: Anklebot (Ankle Robot) |
| High-Reward | Active comparator | High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study Receives: Device: Anklebot (Ankle Robot) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Control
Normalized jerk is a measure of movement smoothness, derived from jerk [(meters)/(second cubed)] divided by the peak velocity (meters/second), leaving values in units of 1/second squared (ie., 1/s^2)
Measured: 3 weeks
Secondary outcomes (2)
Functional Walking Measures
Preferred, self-selected walking velocity measured in centimeters/second (i.e., cm/s).
Measured: 3 weeks
EEG Spectral Coherence Estimates
EEG coherence reflects the degree to which brain regions communicate. It is derived from calculating the degree of association between regions in specified frequency bandwidths; it is like a correlation, except that the values range from 0-1 instead of -1 to 1, so technically there are no units as it is a coefficient. Higher coherence values indicate stronger associations between regions.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland
- Responsible party
- Sponsor
- Investigators
- Ronald N Goodman, PhD, Principal investigator, VA Maryland Health Care System, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072032
- Sponsor's protocol ID
- A7251-W
- Other IDs
- HP-00043705
- Acronym
- AbotMot
- Status last verified
- May 2016
- First submitted
- 17 Feb 2010
- Last updated
- 30 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Goodman RN, Rietschel JC, Roy A, Jung BC, Diaz J, Macko RF, Forrester LW. Increased reward in ankle robotics training enhances motor control and cortical efficiency in stroke. J Rehabil Res Dev. 2014;51(2):213-27. doi: 10.1682/JRRD.2013.02.0050.
PubMed 24933720
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical and Biomechanical Dynamics of Ankle Robotics Training in Stroke
- ClinicalTrials.gov ID
- NCT01072032
- Acronym / sponsor ID
- AbotMot / A7251-W
- Conditions
- Cerebral Stroke
- Keywords
- EEG, Robotics (ankle), Motor-learning, Brain Plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Maryland
- Study start
- May 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Posted 30 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reduced mobility is often a long-term problem facing those who have chronic leg weakness resulting from stroke. Recent innovations in stroke therapy have applied motor learning principles to improve motor skills through regular practice of activities using the weaker limb. Because the ankle provides critical torques for normal walking and mobility function, impairments at the affected ankle pose a major limitation to achieving optimal mobility recovery. To address this we have developed a novel ankle robot (Anklebot) to enhance physical therapy for improving walking and mobility after stroke. This computer controlled device provides assistance when users cannot complete a movement, but will not assist if the user is active.
Motor learning requires active involvement in task-related practice to mediate brain plasticity. While voluntary movement is important to remodel motor control circuits, the brain mechanisms of reward and motivation also can play an important role. Core brain networks involved in reward and motivation increase a person's involvement with their surroundings, to focus attention and to prompt one to approach reward and avoid punishment. This increased involvement and the elevated emotions associated with it have been shown to enhance performance, memory and learning.
The purpose of this study is to investigate responses of brain and motor behavior of stroke patients who use the Anklebot during a 3-week / 3-session/week motor learning based training. These responses are compared to a 3-week delayed entry period in which the participants will perform an at-home walking program of equal time. After the 3-week delayed entry walking program, subjects are divided into low and high reward-feedback groups. The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the researchers. The high-reward group receives cumulative scores and ongoing social support, are eligible for prizes during each session and at the study's completion. All subjects play the games as noninvasive electroencephalography and electromyography record brain and muscle activity. In addition to analyzing brain information before and after the Anklebot training, ankle motor control and walking functions are also assessed immediately before and after the first and last robotic training sessions.
Detailed description
After informed consent is obtained, this pilot study will require at least eleven visits for all subjects. The first visit will entail screening and eligibility tests that last about 3 hours and will occur at the VAMC (Veteran's Administration Medical Center) in the Geriatric Assessment Clinic (GAC). The second and third visits will last approximately 3 hours at the VAMC Human Motor Performance Laboratory and will involve collection of noninvasive EEG, surface EMG and ECG, and practice of ankle movements by using the ankle robot to play video games. In addition measures of gait and balance function will be assessed pre- and post- the Anklebot training. For the next 3-weeks the subjects will take part in an at-home, monitored (log) walking program. The next seven visits (the training program) entail further practice of ankle movements by using the ankle robot to play video games, collection of motor control data but not the collection of any electrophysiological data.. Visit eleven (final) is the same as visits 2 \& 3.
Visit 1: Screening evaluations include review of medical records, medical and neurologic examinations to determine eligibility. Clinical evaluations will also include the Mini Mental State Exam (MMSE) and the Center for Epidemiologic Study (CES-D). Clinical suspicion or evidence on these screening instruments of dementia, depression, or other cognitive deficits that could interfere with the study will preclude further study evaluation and prompt referral to psychiatry or other appropriate health professional for further evaluation. The Automated Neuropsychological Assessment Metrics (ANAM) is also administered as a comprehensive neuropsychological tool for measuring multiple facets of neuropsychological processes that pertain to cognitive function and motor learning. In addition participants will be asked to walk 10 meters 3 times across a gait measuring mat at their preferred speed while in a safety harness and accompanied (not assisted) by an experienced research assistant. This will help determine their deficit severity for grouping during data analysis. Finally, a standard neurological examination is conducted by medically credentialed staff.
Visit 2 \& 3 \& 11: After study enrollment and medical screening, subjects will be tested with the Anklebot while EEG, EMG, and heart rate (ECG) are recorded.
First, subjects will be fitted with a stretch-lycra cap that houses 64 recessed EEG sensors formed from tin. The participant's skin will be lightly abraded or rubbed with the end of a Q-tip at each sensor site to remove oil and dead epidermal tissue to establish good conductance of the EEG signal. The skin will not be broken. Using a blunt applicator attached to a syringe, an FDA-approved non-toxic conducting gel will then be applied through an opening in each of the 64 recording sensors to establish continuous contact of the gel between the skin at the recording sites and the corresponding sensors. Recording sensors will also be positioned on the skin above and below the left eye to monitor eye movements as well as on both ear lobes to serve as "non-brain" reference sites. A ground electrode site will be applied in the frontal region. The eye-channel and reference sites will be lightly abraded with a pad, rubbed with alcohol, and prepared with the conducting gel to enable continuous connection between the scalp and the sensor surface. Also, surface EMG electrodes will be applied to tibialis anterior, gastrocnemius, and, if needed, the peroneal muscles of the paretic leg. Leads for ECG recording will be applied bilaterally to locations immediately inferior to the clavicles.
Once the set-up is complete, subjects will be asked to walk 10 m over an instrumented gait mat to record gait parameters during 3 preferred and 3 fastest walking trials. Subjects will be asked to repeat these walking tasks while performing a concurrent cognitive task consisting of solving and verbally reporting answers to simple arithmetic problems. They will wear a gait belt and be attended closely by research staff as they walk and receive seated rests as required to prevent fatigue. A second test will measure balance control by recording 30 second trials of postural sway during quiet standing on a force plate. Three balance conditions include eyes open, eyes closed, and eyes open while performing a concurrent cognitive task consisting of solving and verbally reporting answers to simple arithmetic problems. Seated rests will be provided as needed.
After baseline functional testing participants will be seated in a chair and the ankle robot will be attached to their paretic leg by means of an orthopedic knee brace and an orthopedic shoe. Pads and cushioning will be applied as needed for proper fitting, and the knee brace will be mounted to the chair for stability. The leg will rest on a cushioned support with the knee at 45 degrees and the foot free to move.
Once the set-up is completed, subjects will be asked to "play" a series of videogames by plantar- or dorsi-flexing the paretic ankle to move a corresponding cursor on a computer screen in order to hit slowly moving targets. The first game is about two-minutes duration and is played without robotic assistance to assess subjects' baseline motor control and ability. Subsequently, 6 games of about 4-minutes duration will provide differing levels of robotic support to guide or encourage the subjects to complete the prescribed ankle movements. The nature and amount of robotic support will be varied across the session to promote short-term motor learning and control of the paretic ankle. Upon completion of the performance-based training series, a repeat of the two-minute unassisted game completes the session.' Finally, subjects will be asked to repeat the postural sway and walking tests as before.
Visits 4-10: participants will be seated in a chair and the ankle robot will be attached to their paretic leg by means of an orthopedic knee brace and an orthopedic shoe. Pads and cushioning will be applied as needed for proper fitting, and the knee brace will be mounted to the chair for stability. The leg will rest on a cushioned support with the knee at 45 degrees and the foot free to move.
Once the set-up is completed, subjects will be asked to "play" a series of videogames by plantar- or dorsi-flexing the paretic ankle to move a corresponding cursor on a computer screen in order to hit slowly moving targets. The first game is about two-minutes duration and is played without robotic assistance to assess subjects' baseline motor control and ability. Subsequently, 6 games of about 4-minutes duration will provide differing levels of robotic support to guide or encourage the subjects to complete the prescribed ankle movements. The nature and amount of robotic support will be varied across the session to promote short-term motor learning and control of the paretic ankle. Upon completion of the performance-based training series, a repeat of the two-minute unassisted game completes the session. During these training sessions no electrophysiological data will be acquired, only motor control data acquired by the Anklebot itself.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Reward | Experimental | Device: Anklebot (Ankle Robot)Low-Reward Anklebot training Group: The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team. |
| High-Reward | Active comparator | Device: Anklebot (Ankle Robot)High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischemic or hemorrhagic stroke greater than 3 months prior
- Residual hemiparetic gait with observable asymmetry in the gait pattern.
- Women or men aged 21 to 85 years
- Completed all conventional physical therapy.
- Adequate language and neurocognitive function to participate in training, testing, and to give informed consent.
Key exclusion criteria (5 listed)
- MMSE score < 23 (9th grade education or more) or MMSE score < 17 (8th grade education or less)
- CES-D score > 16
- Clinical history of orthopedic, chronic pain or severe neuromuscular disorders restricting participation in a short term ankle movement training paradigm.
- Severe or global receptive aphasia which confounds reliable testing and training.
- Women of child-bearing potential, if there is any self-reported chance that they may be pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anklebot (Ankle Robot)Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery | Device | High-Reward, Low-Reward |
Primary outcome
Motor Control
Time frame: 3 weeks
Normalized jerk is a measure of movement smoothness, derived from jerk [(meters)/(second cubed)] divided by the peak velocity (meters/second), leaving values in units of 1/second squared (ie., 1/s^2)
2 secondary outcomes
Functional Walking Measures
Time frame: 3 weeks
EEG Spectral Coherence Estimates
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24933720Goodman RN, Rietschel JC, Roy A, Jung BC, Diaz J, Macko RF, Forrester LW. Increased reward in ankle robotics training enhances motor control and cortical efficiency in stroke. J Rehabil Res Dev. 2014;51(2):213-27. doi: 10.1682/JRRD.2013.02.0050.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald N Goodman, PhD principal investigator
VA Maryland Health Care System, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anklebot (Ankle Robot) in people with Cerebral Stroke, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Control (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01072032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.